Stop omalizumab: a multicenter follow up study after discontinuation in pediatric patients with severe asthma

Few data are available on clinical and laboratory history after discontinuation of Omalizumab in children with severe asthma. Aim: to evaluate children with severe allergic asthma after Omalizumab withdrawal. Methods: this is a longitudinal cohort study in children with severe asthma treated for at least 2 years with Omalizumab, that was discontinued after a good clinical response. We analyzed at the time of withdrawal (T0), and at 3 (T1), 6 (T2), and 12 months (T3) after discontinuation the followings: asthma control (questionnaires), spirometry (GLI reference values), quality of life (PAQLQ), and markers of Th2-inflammation (FeNO, blood eosinophils, total IgE). Results: we evaluated so far 14 children followed up at least to T2. Ten of 14 were males; median age was 15 years; duration of Omalizumab treatment 2-6 years (median: 3). At T2, all showed good symptoms control (median GINA score remained 0), even if 2 experienced asthmatic exacerbations (AE) (one child 1 AE and the other 2 AE). Only the child with 2 AE required an increase in maintenance therapy. FEV1 did not change significantly (median: T0 92% pred and T2 90,6 %pred; z-score T0: -0,64 and T2: - 0,80; p=0,18). Overall, quality of life was good (median PAQLQ at T0: 6,9; at T3: 7.0; p=0,28). 10/10 patients followed up to T3 maintained good control of the disease and only 1 had an AE. Conclusions: with the limit imposed by the number of patients enrolled so far, these preliminary data show that a number of patients have good asthma control after discontinuation of Omalizumab after 6 months, and some also after 12 months. Recruitment and follow-up are ongoing.